Acella Pharmaceuticals – Recall of NP Thyroid® (thyroid)
Acella Pharmaceuticals announced a voluntary, consumer-level recall of 35 lots of 15 mg, 30 mg, 60 mg, 90 mg and 120 mg NP Thyroid (thyroid) tablets because testing has found these lots to be subpotent. The products contain less than 90% of the labeled amount of liothyronine (T3) and/or levothyroxine (T4). April 29, 2021
BD – Recall of ChloraPrep™ Hi-Lite Orange™ (chlorhexidine gluconate/isopropyl alcohol)
BD announced a voluntary, user-level recall of specific lots of ChloraPrep Hi-Lite Orange 26 mL applicator (2% w/w chlorhexidine gluconate and 70% v/v isopropyl alcohol) due to a defective applicator. April 20, 2021
Long-Term Drug Shortage – Zerbaxa® (ceftolozane/tazobactam)
The drug shortage of Merck’s Zerbaxa (ceftolozane/tazobactam) injection is ongoing. Zerbaxa has been unavailable for at least 90 days due to requirements related to complying with good manufacturing practices. April 23, 2021
Grifols – Withdrawal of Gamunex-C® (immune globulin [human])
Grifols Therapeutics announced a voluntary, consumer-level withdrawal of one lot of Gamunex-C (immune globulin [human]) injection due to a higher rate of allergic/hypersensitivity type reactions, a small number of which were considered medically significant. April 27, 2021
Jemperli™ (dostarlimab) – New drug approval
The FDA announced the approval of GlaxoSmithKline’s Jemperli (dostarlimab-gxly), for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer (EC), as determined by an FDA-approved test, that has progressed on or following prior treatments with a platinum-containing regimen. April 22, 2021
Zynlonta™ (loncastuximab tesirine-lpyl) – New drug approval
ADC Therapeutics announced the FDA approval of Zynlonta (loncastuximab tesirine-lpyl), for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma. April 23, 2021
J&J COVID-19 Vaccine – ACIP Recommends Continued Use
The CDC’s Advisory Committee on Immunization Practices (ACIP) convened an emergency meeting to reassess the risk benefit profile of the Johnson & Johnson (J&J) coronavirus vaccine. April 23, 2021
Diovan® (valsartan) – Expanded indication
The FDA approved Novartis’ Diovan (valsartan), for the treatment of hypertension, to lower blood pressure in adults and pediatric patients one year of age and older. April 19, 2021
Ragwitek® (short ragweed pollen allergen extract) – Expanded indication
ALK-Abelló announced the FDA approval of Ragwitek (short ragweed pollen allergen extract), for the treatment of short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen. Ragwitek is approved for use in persons 5 through 65 years of age. April 19, 2021